FDA.reportPublic FDA data

NDC 52389-656-01 - Diurex Ultimate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
52389-656
Requested NDC
52389-656-01
Package NDCs from labels
52389-656-01, 52389-656-60
Manufacturer
Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC
Effective date
2026-06-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diurex UltimateKobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC2026-06-08HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-656-01DiurexUltimate30 in 1 BLISTER PACKTABLET, FILM COATED3012
52389-656-60DiurexUltimate2 in 1 CARTONTABLET, FILM COATED212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-656DIUREX ULTIMATE (CAFFEINE) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]12Current NDC, Legacy NDC, 2 package rows20250416_c6debbfe-6061-463f-8f17-fb240c6f1bab.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 97 of 162 · 3,223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cicapair Soothing Color Correcting Treatment Cica Complex Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEHave & Be Co., Ltd.32c1aba6-5e29-aba9-e063-6394a90a8e562025-04-14WarningsExact identifier
unii: 15FIX9V2JP
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRYOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC07701e11-8a7e-44c5-b46e-5b48264eacad2025-04-14WarningsExact identifier
unii: 15FIX9V2JP
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEAurolife Pharma, LLCf9fde75d-7def-48fc-a2b0-727f677f60012025-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
Arthriten Inflammatory Pain FormulaACETAMINOPHEN, ASPIRIN, CAFFEINEKobayashi Healthcare International, Incc280ca89-4fb5-4050-90ee-d706a550a1ef2025-04-11WarningsExact identifier
unii: 3G6A5W338E
Diurex MaxPAMABROMKobayashi Healthcare International, Inc.37dfece3-d570-4ab2-ba95-af6eb1f3acd42025-04-11WarningsExact identifier
application number: M027
Rolaids Advanced Antacid Anti-gas Mixed BerryCALCIUM CARBONATE AND MAGNESIUM HYDROXIDE AND SIMETHICONEChattem, Inc.3884c05a-a593-424e-88b3-be962e73488e2025-04-10WarningsExact identifier
unii: H0G9379FGK
Kroger Wild Berry Antacid ChewsCALCIUM CARBONATEKroger326e3775-d7f9-2fd9-e063-6294a90a059b2025-04-10WarningsExact identifier
unii: H0G9379FGK
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATEBayer HealthCare LLC.ce9e6acb-a38b-4c9b-a7e8-3e1c2a49a3242025-04-10WarningsExact identifier
application number: M027
unii: 3G6A5W338E
Bayer Back and Body Extra StrengthASPIRIN,CAFFEINEBayer HealthCare LLC.0c77c484-6caf-12ca-e054-00144ff88e882025-04-10WarningsExact identifier
unii: 3G6A5W338E
Smoothing Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDANIEL BEHROOZAN MD A MEDICAL CORPORATION327246c2-9d7a-2d34-e063-6294a90a5fb72025-04-10Exact identifier
unii: 15FIX9V2JP
Diurex Water PillsCAFFEINE, MAGNESIUM SALICYLATEKobayashi Healthcare International, Inc.e02a39f9-1c8c-4d38-b394-3f5b7062932c2025-04-10WarningsExact identifier
application number: M027
unii: 3G6A5W338E
Clarity Rx Physical Skin Defense SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.b5111012-97b9-4908-95a0-d09595f9c4d92025-04-10WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.13e5085f-df2b-46b2-b063-e58ce43799052025-04-09WarningsExact identifier
unii: 15FIX9V2JP
Calcium Carbonate 750 mgCALCIUM CARBONATE 750 MG - ASSORTED BERRIESCVS Pharmacy.Inc.23a76a4f-8c41-b9d0-e063-6394a90a19c52025-04-09WarningsExact identifier
unii: H0G9379FGK
BERKLEY JENSEN ULTRA STRENGTHANTACID CALCIUM CARBONATEBJWCc7eedcbf-3b07-4cd3-937b-c56d7cc5bc572025-04-08WarningsExact identifier
unii: H0G9379FGK
Extra Strength Antacid Smooth Dissolving - Assorted FruitCALCIUM CARBONATETARGET CORPORATION28fc38a7-f7a0-a6a5-e063-6294a90af94c2025-04-05WarningsExact identifier
unii: H0G9379FGK
Extra Strength Antacid Smooth dissolving - Berry Fusion FlavorsCALCIUM CARBONATETARGET CORPORATION28fce33f-c561-1512-e063-6294a90a111c2025-04-05WarningsExact identifier
unii: H0G9379FGK
Ultra Strength Antacid Assorted BerriesCALCIUM CARBONATERite Aid840a617d-d006-4a9b-b98a-8a5ed9af0f402025-03-31WarningsExact identifier
unii: H0G9379FGK
Ultra Strength Antacid PeppermintCALCIUM CARBONATERite Aid3cb46f74-7a62-4b27-beac-a3c055a282152025-03-31WarningsExact identifier
unii: H0G9379FGK
Calcium Carbonate 1000 mgCALCIUM CARBONATE 1000 MG - TROPICAL FRUITCVS HEALTH CORP24ceba32-eb32-902f-e063-6394a90a9fd52025-03-28WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.